Atopic DermatitisNCT01326910
Human Testing of an Over-the-Counter (OTC) Cream in Children With Eczema
A study testing Colloidal Oatmeal and Topical Cream in people with Atopic Dermatitis, run by Johnson & Johnson Consumer Products Company Division of Johnson & Johnson Consumer Companies, Inc. at 2 sites in United States.
Trial summary
This three week study will be conducted to determine the safety and efficacy of an over-the-counter (OTC) cream in children with mild to moderate atopic dermatitis. Read more about this study
- Who is it for?
- Ages 6 months to 18 years
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Colloidal Oatmeal and Topical Cream
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 2 sitesUnited States
- Study dates
- Mar 2011to Jun 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Children ages 6 mo- 18 years
- Any ethnicity
- Diagnosed with atopic dermatitis (AD) per Hanifin-Rajka criteria
- Mild to moderate atopic dermatitis per Rajka-Langeland severity index
- Willing to use only provided cream and body wash for duration of study
Who cannot join
- Known sensitivity to investigational products
- Pregnant or breastfeeding
- Severe AD per Rajka-Langeland severity index
- AD requiring class I (super potent) or class II or III (potent) topical steroids
- Requires greater than 2.0 g inhaled or intranasal corticosteroids
- Other skin conditions which may interfere with the scoring of AD
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Hilltop Research
Miamiville, Ohio, 45147
Hilltop Research
St. Petersburg, Florida, 33710
About this study
Official title: A Double-Blind, Randomized, Active-Controlled Clinical Trial to Evaluate the Efficacy and Safety of an Over-the-Counter Cream in the Management of Mild to Moderate Atopic Dermatitis in Children
This three week study will be conducted to determine the safety and efficacy of an over-the-counter (OTC) cream in children with mild to moderate atopic dermatitis.
Read the detailed description
The objective of this trial is to evaluate the efficacy and safety of an OTC colloidal oatmeal skin protectant cream in children with mild to moderate AD in comparison to that of EpiCeram®
- Conditions
- Atopic Dermatitis
- Being tested
- Colloidal Oatmeal, Topical Cream
- Keywords
- Eczema
- Medical subject headings
- Dermatitis, Atopic, Eczema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colloidal OatmealDrug
Also called Not yet marketed
Topical cream applied twice daily (or as needed)
Topical CreamDevice
Also called EpiCeram
Topical cream applied twice daily (or as needed)
| Study group | Role | What they receive |
|---|---|---|
| 19306-127 | Experimental | Experimental Topical cream applied twice daily (or as needed) Receives: Drug: Colloidal Oatmeal |
| 19306-137 | Other | Marketed Topical cream applied twice daily (or as needed) Receives: Device: Topical Cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eczema Area and Severity Index (EASI)
A regional body surface area tabulation based on severity ranging from 0 (none) to 3 (severe), and severity of signs of disease, then multiplied by body area with final calculation ranging from 0-72
Measured: 3 weeks
Secondary outcomes (3)
Interim Eczema Area and Severity Index (EASI)
Number of subjects improved at Week 2 compared to Baseline in EASI. Improved is defined as post baseline EASI score smaller than baseline score.
Measured: Week 2
Assessment of Itch
Subject's or caregiver's assessment of itch, on a 10-cm Visual Analogue Scale (VAS), where 0-no itch, 10-worst itch imaginable
Measured: through Week 3
Investigator's Global Atopic Dermatitis Assessment (IGADA)
An assessment of Atopic Dermatitis based on a 4 point scale where 0 (none) and 3 (severe) are used to describe signs and symptoms in 4 designated body regions. Based on the presence or absence of the total number of signs and symptoms, the final rating will be 0-clear, 1-almost clear, 2-mild, 3-moderate, 4-severe, or 5-very severe.
Measured: through Week 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2011 (estimated)
- Study startMar 2011
- Primary completionMay 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Consumer Products Company Division of Johnson & Johnson Consumer Companies, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Qing Li, MD, PhD, Study director, Johnson & Johnson Consumer and Personal Products Worldwide
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01326910
- Sponsor's protocol ID
- COOADM3002
- Other IDs
- HTR 11-130435-111
- Status last verified
- Jun 2012
- First submitted
- 30 Mar 2011
- Last updated
- 3 Aug 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Lisante TA, Nunez C, Zhang P. Efficacy and safety of an over-the-counter 1% colloidal oatmeal cream in the management of mild to moderate atopic dermatitis in children: a double-blind, randomized, active-controlled study. J Dermatolog Treat. 2017 Nov;28(7):659-667. doi: 10.1080/09546634.2017.1303569. Epub 2017 Apr 2.
PubMed 28366039
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Randomized, Active-Controlled Clinical Trial to Evaluate the Efficacy and Safety of an Over-the-Counter Cream in the Management of Mild to Moderate Atopic Dermatitis in Children
- ClinicalTrials.gov ID
- NCT01326910
- Acronym / sponsor ID
- COOADM3002
- Conditions
- Atopic Dermatitis
- Keywords
- Eczema
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Johnson & Johnson Consumer Products Company Division of Johnson & Johnson Consumer Companies, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2011
- Primary completion
- May 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 31 Mar 2011 (estimated)
- Results
- Posted 3 Aug 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This three week study will be conducted to determine the safety and efficacy of an over-the-counter (OTC) cream in children with mild to moderate atopic dermatitis.
Detailed description
The objective of this trial is to evaluate the efficacy and safety of an OTC colloidal oatmeal skin protectant cream in children with mild to moderate AD in comparison to that of EpiCeram®
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 19306-127 | Experimental | Drug: Colloidal OatmealExperimental Topical cream applied twice daily (or as needed) |
| 19306-137 | Other | Device: Topical CreamMarketed Topical cream applied twice daily (or as needed) |
Who may qualify
- Ages
- 6 months to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Children ages 6 mo- 18 years
- Any ethnicity
- Diagnosed with atopic dermatitis (AD) per Hanifin-Rajka criteria
- Mild to moderate atopic dermatitis per Rajka-Langeland severity index
- Willing to use only provided cream and body wash for duration of study
Key exclusion criteria (6 listed)
- Known sensitivity to investigational products
- Pregnant or breastfeeding
- Severe AD per Rajka-Langeland severity index
- AD requiring class I (super potent) or class II or III (potent) topical steroids
- Requires greater than 2.0 g inhaled or intranasal corticosteroids
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Colloidal OatmealAlso: Not yet marketedTopical cream applied twice daily (or as needed) | Drug | 19306-127 |
| Topical CreamAlso: EpiCeramTopical cream applied twice daily (or as needed) | Device | 19306-137 |
Primary outcome
Eczema Area and Severity Index (EASI)
Time frame: 3 weeks
A regional body surface area tabulation based on severity ranging from 0 (none) to 3 (severe), and severity of signs of disease, then multiplied by body area with final calculation ranging from 0-72
3 secondary outcomes
Interim Eczema Area and Severity Index (EASI)
Time frame: Week 2
Assessment of Itch
Time frame: through Week 3
Investigator's Global Atopic Dermatitis Assessment (IGADA)
Time frame: through Week 3
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28366039Lisante TA, Nunez C, Zhang P. Efficacy and safety of an over-the-counter 1% colloidal oatmeal cream in the management of mild to moderate atopic dermatitis in children: a double-blind, randomized, active-controlled study. J Dermatolog Treat. 2017 Nov;28(7):659-667. doi: 10.1080/09546634.2017.1303569. Epub 2017 Apr 2.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Qing Li, MD, PhD study director
Johnson & Johnson Consumer and Personal Products Worldwide
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Colloidal Oatmeal and Topical Cream in people with Atopic Dermatitis, run by Johnson & Johnson Consumer Products Company Division of Johnson & Johnson Consumer Companies, Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Aug 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eczema Area and Severity Index (EASI) (time frame: 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01326910, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2012.